A Randomized, Double-Blind, Bilateral Comparison Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Bilateral Flank Adiposity
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- 10xBio, LLC
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Volumetric measurements
Study Overview
Brief Summary
The goal of this clinical trial is to test the safety and effectiveness of an injection study drug in decreasing bilateral flank adiposity.
The main question it aims to answer is:
•How safe and effective is the injection study drug in removing bilateral flank adiposity compared to a placebo?
Participants will be:
- Be given injections every month for 5 months over the right and left flanks.
- Be asked to be seen in the clinic for 13 visits and 3 phone call visits during a duration of 1 year.
Detailed Description
Fifteen subjects with bilateral flank adiposity will be enrolled across 1-3 sites in the USA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
1:1 ratio
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is a male or non-pregnant female 18 to 55 years old.
- •Subject has provided written informed consent.
- •Subject has qualifying fat evaluation and skin laxity scores on each right and left flanks.
- •Subject has had a stable body weight for the past 6 months prior to starting study.
- •Subject is willing to undergo test article injections as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
Exclusion Criteria
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject has loose skin in the right and left flank areas, unrepaired abdominal injury or defect, scars, tattoos, or other features that may interfere with evaluation of localized fat, in the opinion of the investigator.
- •Subject has any medical condition or taking medications that affects clotting and/or platelet function
- •Subject has a history of allergy or sensitivity to polidocanol or any of the other ingredients in the test articles.
Arms & Interventions
10XB-101 Solution for Injection, 6.0%
Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments.
Intervention: 10XB-101 Solution for Injection, 6.0% (Drug)
Placebo Solution for Injection
Participants receive Placebo Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments.
Intervention: Placebo Solution for Injection (no active ingredient) (Drug)
Outcomes
Primary Outcomes
Volumetric measurements
Time Frame: 24 weeks after final injection treatment
Change from Baseline until end of study. Volumetric measurements will be obtained on each right and left flanks thru a standard photographic assessment.
Patient Global Impression of Change (PGIC)
Time Frame: 24 weeks after final injection treatment
Change from Baseline on each flank after final treatment. Patient Global Impression of Change (PGIC) is a 7-point bi-directional scale with 1 as much improved and 7 as much worse.
Flank Skin Laxity Scale (FSLS)
Time Frame: 24 weeks after final injection treatment
Change from Baseline on each flank after final treatment. Flank Skin Laxity Scale (FSLS) is a 4 point scale, with a score of 0 for no skin folds, and a score of 3 for severe or worse skin folds.A higher score means a worse outcome.
Clinician Global Impression of Change (CGIC)
Time Frame: 24 weeks after final injection treatment
Change from Baseline on each flank after final treatment. Clinician Global Impression of Change (CGIC) is a 7-point bi-directional scale with 1 as much improved and 7 as much worse.
Secondary Outcomes
No secondary outcomes reported